Mindful Minds: Mindfulness-Based Neurofeedback for Underrepresented College Students

Not Applicable

Recruiting

• Conditions: Academic Performance; Anxiety

• Registration Number: NCT06784934
• Lead Sponsor: Florida International University

Brief Summary

The study examines the efficacy of a mindfulness-based neurofeedback protocol designed to improve academic performance and reduce performance anxiety in racial and ethnic minority college students. Using NeuroSky and BrainTrain technology, the intervention incorporates mindfulness principles to enhance participants' self-regulation skills. Continuous heart rate variability (HRV) data is collected to assess stress levels, sleep, and exercise. The research aims to explore the acceptability and feasibility of this approach, with the goal of addressing academic performance and anxiety in this population.

Detailed Description

The United States has witnessed a notable increase in the enrollment of racial and ethnic minority students (i.e., "The minority racial and ethnic groups defined by Office of Management and Budget's (OMB) are American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or Pacific Islander. The ethnicity used is Latino or Hispanic"). With the rise in college enrollment has also come concerns about the challenges racial and ethnic minority students are facing, such as "experiencing microaggressions, discrimination, imposter syndrome, and negative campus climate," which have been found to contribute to mental health problems for minority college students. Those who identify as more than one race had the highest rate of anxiety (39.8%), followed by American Indian/Alaskan Native (39.1%), Arab/Arab American (35.2%) and Latino (35.2%).6 However, the majority of research about college students' mental health status and treatment is focused on the general college student population, with extensive studies having only small subsets of racial and ethnic minority student representation. Given the ubiquity of mental health challenges in college students, the development of an easily utilized, readily available, inexpensive, with minimal side-effects intervention is needed. Neurofeedback and mindfulness have both been found to show significant improvements in performance enhancement, anxiety reduction, and improved focus/awareness. Through continuous neurofeedback interventions, individuals tend to improve interoceptive awareness and develop mechanisms to facilitate emotional control. Mindfulness meditation can help individuals gain control of their attention, which may, in turn, help to facilitate control of thoughts and emotions. Currently, there is little research on the benefits of neurofeedback using mindfulness-based interventions to improve academic performance in students from racial and ethnic minority backgrounds. This research program responds to the urgent need for targeted interventions to enhance academic success and improve mental health among racial and ethnic minority students in higher education. Using a randomized control trial, 36 participants will be randomly assigned to either the 4-week mindfulness-based neurofeedback intervention or business as usual. The investigators hypothesize that participants in the experimental group will significantly improve test performance and reduce academic anxiety compared to the control group. Focused on examining the acceptability and feasibility of a mindfulness-based neurofeedback intervention, the study aims to address performance anxiety and improve test performance as well as mental health by providing real-time feedback and objective analysis to overcome the limitations of traditional stress management programs. The research also aims to offer a more accessible and practical approach, contributing valuable insights to promote equitable outcomes for underrepresented students.

Study Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-20
• Study Start: 2025-01-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Aged between 18 and 30 years old
• Currently enrolled in a 4-year university
• Individuals from an ethnic or racial minority background (i.e., "The minority racial and ethnic groups defined by Office of Management and Budget's (OMB) are American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or Pacific Islander. The ethnicity used is Latino or Hispanic.")

Exclusion Criteria

• Severe depression (cut off score of 15 or higher on Patient Health Questionnaire 9 (PHQ-9))
• Previously receiving biofeedback training.
• Severe medical condition (e.g., pacemaker, cardiac arrhythmia, hypertension, diabetes).
• Showing symptoms of psychosis
• Having a neurological condition (e.g., Parkinson's disease) that would complicate the interpretation of physiological data.
• Taking medications such as SSRIs, alpha/beta-blockers, or withdrawal or maintenance medications (e.g., Librium, methadone)
• Using substances such as tobacco and illicit drugs, and 8)alcohol consumption as defined by National Institute of Health (NIH) as "more than 2 drinks (1 drink for women) in a day or drinking more than 5 drinks (4 for women) on the same occasion (i.e., at the same time or within a couple of hours of each other) on at least 1 day in the past month" are excluded due to their potential to affect the data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Academic Performance	From enrollment to the end of treatment at 4 weeks	Trier Social Stress Test will be utilized to induce performance anxiety through a mock job interview and mental arithmetic task conducted in front of a non-responsive committee. This test uses a standardized protocol that not only facilitates a more robust evaluation of our intervention but also elevates the ecological validity of the study by assessing its effects in a real-life scenario. The social stress test not only facilitates a more robust evaluation of our intervention but also elevates the ecological validity of the study by assessing its effects in a real-life scenario.
Academic Anxiety with Academic Anxiety Scale	From enrollment to the end of treatment at 4 weeks	The Academic Anxiety Scale (AAS) will be used to examine performance anxiety (Aim 1). This 11-item questionnaire uses a 4-point Likert Scale (1 = not at all typical of me to 4 = very typical of me) and measures broader aspects of academic-based anxiety beyond cognitive factors. The AAS includes items designed to assess apprehension and anxiety in academic settings, with high reliability (split-half Guttman reliability of 0.91 and Cronbach's Alpha of 0.94).
Acceptability	From enrollment to the end of treatment at 4 weeks	Semi-structured interviews will be conducted during the weekly check-ins to further our understanding of the intervention's acceptability utilizing qualitative techniques such as thematic analysis.
Academic Anxiety with Beck Anxiety Inventory	From enrollment to the end of treatment at 4 weeks	The Beck Anxiety Inventory (BAI) will measure generalized anxiety using a 21-item Likert scale (0 to 3) to assess how distressing anxiety symptoms have been over the past week. Scores range from 0 to 63, with levels categorized as minimal (0-7), mild (8-15), moderate (16-25), and severe (30-63). The BAI has been widely used among racially diverse groups. The investigators hypothesize that BAI scores will vary significantly from pre- to post-intervention.
Feasibility	From enrollment to the end of treatment at 4 weeks	Semi-structured interviews will be conducted during the weekly check-ins to further our understanding of the intervention's feasibility utilizing qualitative techniques such as thematic analysis.

Secondary Outcome Measures

Name	Time	Method
Attention with Integrated Visual and Auditory Continuous Performance Test	From enrollment to the end of treatment at 4 weeks	The Integrated Visual and Auditory Continuous Performance Test (IVA-2) will be used to assess attention as a secondary outcome. This computerized test measures both visual and auditory attention, providing an overall score of attentional functioning and response control. It evaluates sustained attention, impulsivity, and processing speed through a series of tasks requiring quick and accurate responses.The scores range from 0 to 145, with a mean of 100 and a standard deviation of 15. Higher scores reflect better performance. Scores of zero are valid, indicating performance 6.65 SD below average. The test includes a validity check (p \< .01) for random responses, allowing scores to be set to zero if effort was made. Rating scales are available for additional validity assessment.
Increased Alpha Activity	From enrollment to the end of treatment at 4 weeks	The NeuroSky device will be used to measure alpha brainwave activity, a marker of relaxation and focused attention, as a secondary outcome. Mindfulness-based neurofeedback training will aim to enhance alpha activity by providing participants with real-time feedback on their brainwave patterns. During each session, participants will learn to modulate their alpha levels through mindfulness techniques, fostering a state of calm alertness. Increased alpha activity is associated with improved emotional regulation, reduced stress, and enhanced cognitive functioning. Pre- and post-intervention alpha activity levels will be compared to evaluate the effectiveness of the mindfulness-based neurofeedback training.
Attention with Mental Stress Assessment	From enrollment to the end of treatment at 4 weeks	The Mental Stress Assessment (MeSA) will also assess attention by measuring physiological responses during tasks designed to induce and evaluate stress-related attentional shifts.
Heart Rate Variability	From enrollment to the end of treatment at 4 weeks	Heart Rate Variability (HRV) will be measured using the OptimalHRV device. We will examine HRV to determine if participants HRV increased from pre- to post-test which would be an indication of improved autonomic nervous system balance.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States